Terazol 3

Product NDC

50458-536

11-digit product format

504580536

Labeler code

50458

Product ID

50458-536_9a055cd8-638b-11ea-a644-412efc2ca371

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

TERCONAZOLE

Dosage form

CREAM

Route

VAGINAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA019964

Marketing category

NDA

Marketing start

1991-02-21

Marketing end

2020-06-15

Substance

TERCONAZOLE

Active strength

8 mg/g

Pharmacologic classes

Azole Antifungal [EPC],Azoles [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record